St. Jude recall
This article was originally published in The Gray Sheet
Firm recalls more than 5,000 of its 6-French Engage introducers used to implant catheters and electrodes into blood vessels during surgery while helping to prevent bleeding. The firm announced the action after learning that the device shaft may separate from the hub or the hub assembly may break, causing potentially life-threatening bleeding. The affected devices were produced between April 27 and June 3, 2010. St. Jude alerted customers in a June 24 letter. FDA placed the recall in the highest-risk Class I category
You may also be interested in...
Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.
Managing partner Corey Goodman said venBio didn’t have trouble closing its fund, because the venture capital firm prepared its investors for an economic downturn months ago.
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.